Assessment of Postoperative Pain After Using Various Intracanal Medication in Patients With Necrotic Pulp

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Calcium Hydroxide Intracanal medication; Drug: Silver Nanoparticles in gel form; Combination Product: Silver nanoparticle/Calcium hydroxide

• Registration Number: NCT03692286
• Lead Sponsor: Cairo University

Brief Summary

To assess the Postoperative Pain after using Silver Nanoparticles with and without Calcium Hydroxide as an Intracanal Medication in Patients with necrotic pulp (RCT)

Detailed Description

When the treatment itself appears to initiate the onset of pain and/or swelling, the result can be very distressing to both the patient and the operator. Patients might even consider postoperative pain and flare-up as a benchmark against which the clinician's skills are measured. Prevalence of postoperative pain or flare-up is, therefore, one of the influencing factors when making a clinical decision. Better management of postoperative pain increases the patients' confidence in dentist's skills and gives positive attitude toward dental profession. In cases with necrotic pulp, the incidence of pain becomes higher, hence testing which intracanal medication is more effective in decreasing the bacteria present within the root canal and subsequently pain is crucial.

Study Timeline

• Study First Submitted: 2018-09-28
• Study First Submitted QC: 2018-09-28
• Study First Posted: 2018-10-02
• Study Start: 2019-06-01
• Primary Completion: 2020-08-18
• Study Completion: 2020-09-18
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-16
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
• Non-pregnant females
• Asymptomatic necrotic mandibular single rooted teeth.
• Normal occlusal contact with the opposing teeth.
• Patients accepting to participate in the study.

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Exclusion Criteria

• Medically compromised patients: Pain levels and healing following treatment would be compromised as these patients have shown higher incidence of pain and lower healing rate.
• Pregnant women: Avoid radiation exposure, anesthesia, and medication.
• If analgesics or antibiotics have been administrated by the patient during the past 12 hours preoperatively might alter their pain perception
• Patients reporting bruxism or clenching: Avoid further pressure on an already inflamed tooth inducing subsequent irritation and inflammation Teeth that shows:
• Association with acute periapical abscess and swelling: Need special treatment steps which could involve additional visits with incision and drainage. Also, it could influence initiation and progression of postoperative pain.
• Greater than grade I mobility or pocket depth greater than 5mm. Need special surgical and/or periodontal therapy.
• No restorability: Hopeless tooth.
• Vital teeth
• Immature teeth
• Radiographic evidence of external or internal root resorption.
• Any criterion, not mentioned in the inclusion criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ca(OH)	Calcium Hydroxide Intracanal medication	Patients receiving calcium hydroxide intracanal medication at the first visit after cleaning and shaping
AgNP	Silver Nanoparticles in gel form	Patients receiving silver nanoparticles in gel form administered as intracanal medication at the first visit after cleaning and shaping
AgNP/Ca(OH)	Silver nanoparticle/Calcium hydroxide	Patients receiving combined Silver nanoparticle/Calcium hydroxide administered as intracanal medication at the first visit after cleaning and shaping

Primary Outcome Measures

Name	Time	Method
Change in post-operative pain	Intra-appointment and post obturation at 4, 24, 48, 72, 96 hours	Numerical (0-10)

Secondary Outcome Measures

Name	Time	Method
Intracanal Bacterial count reduction	1 week	Quantification of Colony forming units per milliliter of agar medium (CFU/mL)
Number of analgesic tablets taken by the patient after endodontic treatment	Within 4 days after the first session and after 1 week from first treatment session	Number

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Manial, Egypt